Summary of the role:
The Manufacturing Head will lead and coordinate all production activities of a medical disposable cartridge and the instrument analyser (reader), through direct reports and associates, to achieve production goals across multiple production lines. The right candidate will be able to lead a manufacturing team, implement cost-effective processes, and scale up activities for point-of-care (POC) diagnostic products by bringing together high-volume, low-mix production strategies, among other similar activities. Meet all required safety, quality, and regulatory compliance commitments in the execution of manufacturing processes.
- Managing end-to-end plant operations including manufacturing, production planning, demand-supply planning, inventory management, compliances, labor relationship management, quality, etc.
- Proactively identify and implement scale-up and process improvements, and cross-functional collaboration to support capacity and future growth
- Vendor and supplier management to ensure materials are at the right inventory levels to meet the OTD of products and strive for improved turns in support of optimizing working capital for the business
- Provide insights into long-term plans and objectives to meet future manufacturing requirements; including specific capital deployment projects to support growth, risk mitigations, and savings initiatives
- Drive employee training and development programs for operators/technicians, including cross-training, kaizen event participation, and development goals.
- Support and ensure procedures and methods to ensure compliance with GMP, ISO, ICMR, CDSCO regulations, and QA/QC medical, state, and local regulatory bodies.
- Find and work with external consultants to solve technical challenges incorporate best practices for large-volume manufacturing and implement DFM techniques to improve manufacturability of the cartridge and reader.
- Develop a strong understanding of the technological platform, and seek to implement continuous improvement with a proactive attitude.
- You will need to build a deep technical aptitude for the cartridge design, components, materials, construction, and assay performance metrics. The same will be required for the reader and its assembly, along with verification/qualification in clinical trials and external validations.
- Building a team of 15+ persons along with the responsibility for their growth in the organization
- Working with R&D to develop project-specific manufacturing timelines and budgets
- Working with a quality team, help develop project-specific manufacturing quality standards per ISO13485
- Hire high-quality team members across manufacturing operations for reader and cartridge.
- Maintain meticulous documentation as required for traceability, QMS compliance, and SOP/STP/DHF creation within the scope of ISO 13485 guidelines.
1. Demonstrated leadership and manufacturing process development skills in a technical environment related to POC medical devices and consumables.
2. Minimum of 10+ years’ experience in a commercial entity that has taken health tech products to market
3. Excellent written and oral communication skills to confidently interface with external partners/customers and lead internal teams to achieve objectives
4. Deep technical knowledge in at least one area related to the manufacturing of IVD products with the ability to solve technical problems through individual effort where required.
• Bachelor’s degree in Engineering, Technology, Business, Manufacturing Management or equivalent
• 10+ years in an operations management position
• Prior experience utilizing lean methodology and tools to improve operations and business processes
• Experience setting and managing budgets to meet quality and commercial targets, including productivity and labor costs
• Demonstrated success managing manufacturing, cycle count, and inventory goals...